Bronchial Asthma
Conditions
Keywords
Asthma, Roflumilast, phosphodiesterase 4 inhibitor
Brief summary
The aim of the study is to investigate the effect of roflumilast (APTA-2217) on lung function in patients with asthma. Roflumilast will be administered orally once daily. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast.
Interventions
DRUGRoflumilast
Sponsors
AstraZeneca
Tanabe Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Inclusion criteria
Main inclusion criteria: * Adult patients with bronchial asthma meeting the Guideline for Prevention and Control of Asthma 2003 (JGL 1998, revised 2nd edition) * No change in asthma treatment during the last 4 weeks prior to the registration * Non-smokers or ex-smokers for 12 months or more * %FEV1 ranging between 60 and 80% Main
Exclusion criteria
* Patients with poorly controlled asthma * Inhalation therapy exceeding low dose during 4 weeks prior to the registration * Concurrent respiratory diseases such as COPD considered to affect the efficacy evaluation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in lung function parameters. | — |
Secondary
| Measure | Time frame |
|---|---|
| pulmonary function test (spirometry), asthma symptoms, rescue medication, evaluation of QOL, asthma exacerbation, adverse events, pharmacokinetics. | — |
Countries
Japan
Contacts
STUDY_DIRECTORAstraZeneca AstraZeneca
AstraZeneca
Outcome results
None listed